This book examines the European Community legislation that regulates the safety of consumer products. Hodges surveys the extent to which this legislation aims to and succeeds in achieving safety for a wide range of products. There are different legal requirements for medicines, machines, electronics, toys and so on, which employ different regulatory mechanisms, including pre-marketing assessment, provision of information, control of the manufacturing environment, post-marketing obligations on producers and authorities, and obligations on distributors and users. Hodges compares the various mechanisms relating to medicinal products, products covered by 'New Approach' Directives, cosmetics, biocides, tobacco products, and consumer products covered by the General Product Safety Directive, and asks why particular mechanisms are used, or not used for different products.
The book then moves on to consider what is meant by product 'safety', demonstrating the relativity of this concept. Hodges highlights an important problem: that consumers, the media, and experts can all have differing ideas on the level of safety that is relevant and acceptable. Hodges contends that the systems are in need of review, to ensure they work effectively and give value for money. In some cases, there is an need for more or less control. He argues for more systematic collection of safety data, and for consistecy in surveillance and enforcement mechanisms across Europe, pointing towards the need for a European Product Safety Agency.
Rezensionen / Stimmen
Christopher Hodges has been an inside practitioner in the field of consumer products safety. He has blended those unique insights with academic research to produce a thought provoking book. His vision of a more coherent regulatory structure with informed and balanced debates about what safety standards best suit the European market is a model that has much to commend itself. Hopefully this work will encourage regulators to bear these principles in mind. * Geraint Howells, Public Law *
Sprache
Verlagsort
Zielgruppe
Für Beruf und Forschung
Scholars od EU law and regulation, practitioners in EU law, or working in industry.
Produkt-Hinweis
Fadenheftung
Gewebe-Einband
Illustrationen
numerous figures & tables
Maße
Höhe: 234 mm
Breite: 156 mm
Dicke: 19 mm
Gewicht
ISBN-13
978-0-19-928255-5 (9780199282555)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Klassifikation
Christopher Hodges is a Visiting Research Fellow at the Centre for Socio-Legal Studies, Oxford, and Partner at CMS Cameron McKenna.
Autor*in
Visiting Research Fellow at the Centre for Socio-Legal Studies, Oxford and Partner, CMS Cameron McKenna
Table of Legislation ; Table of Cases ; List of Figures ; List of Tables ; List of Abbreviations ; Introduction ; 1. Theoretical aspects of regulation ; PART ONE: DESCRIPTION OF THE MAIN REGULATORY SYSTEMS AT COMMUNITY LEVEL ; 2. Introduction ; 3. The limits on the Community's jurisdictional competence in product safety legislation ; 4. Medicinal products ; 5. New Approach products ; 6. Biocides, cosmetics, tobacco, and general consumer products ; PART TWO: PROCEDURAL MECHANISMS FOR SAFETY ; 7. Introduction ; 8. Pre-market assessment: authorization to market ; 9. Control of the manufacturing environment and process ; 10. Providing information ; 11. Producers' Post-marketing obligations ; 12. The role of the authorities in post-marketing safety ; 13. Control of distribution ; 14. Obligations on users ; 15. Conclusions on safety mechanisms ; PART THREE: THEORETICAL ISSUES AND CONCLUSIONS ; 16. Introduction ; 17. The Community institutions involved and their mechanisms of governance ; 18. Safety and risk ; 19. Conclusions ; APPENDICES ; Appendix 1 The Pharmacovigilance System ; Appendix 2 Statistics on the safety of general consumer products ; Appendix 3 Statistics on the safety of medicinal products ; Appendix 4 Statistics on the safety of electrical products ; Appendix 5 Modules for conformity assessment procedures under the New Approach ; BIBLIOGRAPHY ; INDEX